[Federal Register: February 3, 2003 (Volume 68, Number 22)]
[Page 5297-5298]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Advisory Committee for Pharmaceutical Science; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Advisory Committee for Pharmaceutical Science.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on March 12, 2003, from 
8:30 a.m. to 5 p.m. and March 13, 2003, from 8:30 a.m. to 5 p.m.
    Location: Center for Drug Evaluation and Research Advisory 
Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD.
    Contact Person: Kathleen Reedy or Carolyn Jones, Center for Drug 
Evaluation and Research (HFD-21), Food and Drug Administration, 5600 
Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), 
Rockville, MD 20857, 301-827-7001, or e-mail: REEDYK@cder.fda.gov, or 
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 
in the

[[Page 5298]]

Washington, DC area), code 12539. Please call the Information Line for 
up-to-date information on this meeting.
    Agenda: On March 12, 2003, the committee will: (1) Receive a final 
report from the Process Analytical Technology Subcommittee and provide 
direction to the Manufacturing Subcommittee; (2) receive an update on 
sterile products produced by aseptic processing; (3) discuss and 
provide direction for future subcommittees: Biopharmaceutics 
Subcommittee and Microbiology Subcommittee; (4) discuss and provide 
comments on topical dermatological drug product nomenclature; and (5) 
discuss and provide comments on topical dermatological bioequivalence, 
methods development. On March 13, 2003, the committee will: (1) Discuss 
and provide direction for future subcommittee: Pharmacology/Toxicology 
Subcommittee; (2) receive an update on the Office of Pharmaceutical 
Science research projects; (3) discuss and provide comments on dose 
content uniformity, parametric interval test for aerosol products; (4) 
discuss and provide comments on levothyroxine bioequivalence; and (5) 
discuss and provide comments on comparability protocols.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person by March 3, 2003. 
Oral presentations from the public will be scheduled between 
approximately 1:30 p.m. to 2 p.m. on March 12, 2003, and 11:30 a.m. to 
12 noon on March 13, 2003. Time allotted for each presentation may be 
limited. Those desiring to make formal oral presentations should notify 
the contact person before March 3, 2003, and submit a brief statement 
of the general nature of the evidence or arguments they wish to 
present, the names and addresses of proposed participants, and an 
indication of the approximate time requested to make their 
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Carolyn Jones at 
least 7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: January 27, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-2459 Filed 1-31-03; 8:45 am]